Background: In randomized, controlled trials of open-angle glaucoma (OAG) or ocular hypertension (OHT),\nbimatoprost 0.01 % improved tolerability while retaining the intraocular pressure (IOP)-lowering efficacy of\nbimatoprost 0.03 %. Given geographic/racial differences in glaucoma presentation, the APPEAL study assessed the\noccurrence and severity of hyperemia produced by bimatoprost 0.01 %, and its efficacy, in the Taiwanese clinical\nsetting.\nMethods: In this multicenter, open-label, observational study, treatment-na�¯ve and previously treated patients with\nOHT or OAG received once-daily bimatoprost 0.01 % for 12 weeks. Hyperemia (primary endpoint) was graded at\nbaseline, week 6, and week 12 using a photonumeric scale (0, +0.5, +1, +2, +3), grouped (â�¤ +1, none to mild; â�¥ +2,\nmoderate to severe), and reported as unchanged from baseline, improved, or worsened. IOP assessments followed\nthe same schedule. Supplemental efficacy analyses were conducted based on previous therapies.\nResults: The intent-to-treat population (N = 312) included treatment-na�¯ve (13.5 %) and previously treated (86.5 %)\npatients; mean age was 53.3 years. At baseline, 46.3 % of previously treated patients were receiving prostaglandin\nanalog (PGA) monotherapy. At week 12, 91.2 %, 5.9 %, and 2.9 % of treatment-na�¯ve patients exhibited unchanged,\nworsened, and improved hyperemia from baseline, respectively; 77.9 %, 12.9 %, and 9.2 % of previously treated\npatients showed no change, worsening, and improvement, respectively. There were no statistically significant shifts\nin hyperemia severity in either group, or in subgroups based on previous use of any PGA, any non-PGA, latanoprost, or\ntravoprost monotherapies. In treatment-na�¯ve patients, mean IOP reduction from baseline (18.0 �± 3.8 mm Hg) was 3.6\nmm Hg at week 12 (P < 0.0001); 83.3 % had baseline IOP â�¤ 21 mm Hg. In previously treated patients, mean additional\nIOP reduction from baseline (17.8 �± 3.9 mm Hg) was 2.6 mm Hg (P < 0.0001); similar results were observed in patient\nsubgroups based on previous therapies. Conclusions: In the Taiwanese clinical setting, bimatoprost 0.01 % provided significant IOP lowering in treatment-na�¯ve\npatients (regardless of baseline IOP) and previously treated patients (even those with relatively low IOP on other\ntherapies), while causing no significant changes in hyperemia from baseline.
Loading....